(62 days)
The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care users in the quantitative determination of pH, pCO2, pO2, sO2 %, Na+, K+, Cl-, iCa++, Glucose, Lactate, Hematocrit and Hemoglobin in whole blood. Whole blood pH, pCO2, and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Stat Profile pHOx Analyzer." It primarily discusses regulatory approval and does NOT contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for this specific document. To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed device submission.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 8 2002
Mr. Paul W. MacDonald Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, MA 02254-9141
K014295 Re: Trade/Device Name: Stat Profile pHOx Analyzer Regulation Number: 21 CFR 862.1120; 21 CFR 862.1150; 21CFR 862.1660; 21 CFR 864.5600; 21 CFR 864.5620 Regulation Name: Blood gases (Poo2, Po2) and blood pH test system; Calibrator; Quality control material (assayed and unassayed); Automated hematocrit instrument; Automated hemoglobin system Regulatory Class: Class II, Class II; Class II; Class II; Class I Product Code: CHL; JIX; GKF; GKR; JJS Dated: December 27, 2001 Received: December 28, 2001
Dear Mr. MacDonald:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have rowe and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou mayy ato se or visions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket rills letter will and w you as organizatial equivalence of your device to a legally marketed noutheation. The I Dr intention for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 II you desire specific acrice is a received devices), please contact the Office of Compliance at additionally 607.10 for its for questions on the promotion and advertising of your device, (301) 594-4566. Tructionally, rollance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small illionifacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrb/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K014295
Device Name: Stat Profile pHOx Analyzer
Indications for Use:
Intended Use
The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health The Stat Profile prox Analyzen is thenever in the suage for the suagnitiative determination
care professionals and for Point-of-Care users in the suantitative determination care professionals and for Tome-on newage in a long-en-strant whole blood. Whole blood of pri, pcoz, poz, ooz », not and his in the diagnosis and treatment of lifethreatening acid-base disturbances.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
§10(k) Number K014295
(Please Do Not Write Below This Line- Continue on another Page IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Rx L
OTC
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.